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MNH — Orthosis, Spondylolisthesis Spinal Fixation Class II

FDA Device Classification

Classification Details

Product Code
MNH
Device Class
Class II
Regulation Number
888.3070
Submission Type
Review Panel
OR
Medical Specialty
Orthopedic
Implant
Yes

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K162066reliance medical systemsReliance Spinal Screw SystemDecember 2, 2016
K162801l and k biomed coCastleLoc Spinal Fixation SystemNovember 3, 2016
K162143innovasisFixxSure® X-LinkSeptember 23, 2016
K161151canwell medical coSpinal fixation systemSeptember 21, 2016
K162189u and i corporationANAX™ 5.5 Spinal SystemAugust 30, 2016
K151362hung chun bio-s coHC Spinal SystemMay 5, 2016
K153404zavationZavation Spinal SystemApril 21, 2016
K160020captiva spineCaptiva Spine and CapLOX II/TowerLOX Pedicle Screw SystemMarch 2, 2016
K143013changzhou dingjian medical appliance coSpinal Inner Fixation SystemDecember 11, 2015
K151695spineartRomeo posterior osteosynthesis systemSeptember 10, 2015
K151116captiva spineCapLOX II/TowerLOX Pedicle Screw SystemJune 26, 2015
K150283republic spineRepublic Spine Dark Star Spinal SystemApril 29, 2015
K142798medicrea internationalPASS LP Spinal SystemMarch 25, 2015
K143417u and i corporationANAX 5.5 Spinal SystemFebruary 25, 2015
K143377spinefrontierPedFuse Pedicle Screw SystemFebruary 12, 2015
K142957jiangsu ideal medical science and technology coIdeal pedicle screw spinal systemJanuary 30, 2015
K142655chin bone techniqueCB PROT II Posterior Spinal SystemJanuary 26, 2015
K140359valorem surgicalMAXIMIS SPINAL FIXATION SYSTEMJanuary 7, 2015
K142290suzhou kangli orthopaedics instrument coKangLi pedical screw spinal systemNovember 24, 2014
K134011changzhou dean medical instrument coGENERAL SPINAL SYSTEMSeptember 3, 2014